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Diss Factsheets
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EC number: 259-452-4 | CAS number: 55039-14-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Justification for read across is detailed in the report attached to the IUCLID section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation, other
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Justification for read across is detailed in the report attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- None
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 70 mg of was instilled into each eye.
- Duration of treatment / exposure:
- The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.
- Observation period (in vivo):
- 24 hours
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- Six albino rabbits are used for each test substance.
- Details on study design:
- None
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1.
- Other effects:
- None
- Interpretation of results:
- other: Not classified
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- non-irritant to the eyes.
- Executive summary:
In a study performed to determine the eye irritation potential of FAT 20013, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013 is considered to be a non-irritant to the eyes.
Numerical Scores awarded to the ocular reactions elicited by FAT 20013/A:
Animal Number | Region of eye | Day | |||||||
1 | 2 | 3 | 4 | 7 | 14 | 21 | |||
1 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 4 | 0 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 4 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 2 | 2 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 2 | 2 | 0 | 0 | 0 | 0 | 0 | ||
4 | Cornea | 5 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 6 | 4 | 2 | 2 | 2 | 2 | 0 | ||
TOTAL | 11 | 4 | 2 | 2 | 2 | 2 | 0 | ||
5 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 6 | 2 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 6 | 2 | 0 | 0 | 0 | 0 | 0 | ||
6 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 8 | 2 | 2 | 0 | 0 | 0 | 0 | ||
TOTAL | 8 | 2 | 2 | 0 | 0 | 0 | 0 | ||
Total Score | 37 | 16 | 4 | 2 | 2 | 2 | 0 | ||
Mean / rabbit | 6 | 3 | <1 | <1 | <1 | <1 | 0 | ||
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar substance 01 of Acid Black 213
- IUPAC Name:
- Similar substance 01 of Acid Black 213
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- None
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- None
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 70 mg of was instilled into each eye.
- Duration of treatment / exposure:
- The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.
- Observation period (in vivo):
- 24 hours
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- Six albino rabbits are used for each test substance.
- Details on study design:
- None
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1.
- Other effects:
- None
Any other information on results incl. tables
Numerical Scores awarded to the ocular reactions elicited by FAT 20013/A:
Animal Number | Region of eye | Day | |||||||
1 | 2 | 3 | 4 | 7 | 14 | 21 | |||
1 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 4 | 0 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 4 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 2 | 2 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 2 | 2 | 0 | 0 | 0 | 0 | 0 | ||
4 | Cornea | 5 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 6 | 4 | 2 | 2 | 2 | 2 | 0 | ||
TOTAL | 11 | 4 | 2 | 2 | 2 | 2 | 0 | ||
5 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 6 | 2 | 0 | 0 | 0 | 0 | 0 | ||
TOTAL | 6 | 2 | 0 | 0 | 0 | 0 | 0 | ||
6 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Conjuctivae | 8 | 2 | 2 | 0 | 0 | 0 | 0 | ||
TOTAL | 8 | 2 | 2 | 0 | 0 | 0 | 0 | ||
Total Score | 37 | 16 | 4 | 2 | 2 | 2 | 0 | ||
Mean / rabbit | 6 | 3 | <1 | <1 | <1 | <1 | 0 | ||
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- non-irritant to the eyes.
- Executive summary:
In a study performed to determine the eye irritation potential of FAT 20013, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013 is considered to be a non-irritant to the eyes.
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